BD SWAB ALCOHOL
Received Dec 2, 2021 · Event occurred Nov 3, 2021
Report 1920898-2021-01259 · MDR key 12920493
Device
Generic name
Pad, Alcohol, Device Disinfectant
Manufacturer
Bd Medical - Diabetes CareCatalog number
326895
Lot number
0201275
Product problems
- Missing Information
- Missing Information
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
IT WAS REPORTED THAT THE EXPIRATION DATE IS MISSING ON SHELF PACK AND INDIVIDUAL PACKAGING OF A BD SWAB ALCOHOL. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED BY THE CONSUMER, THE EXPIRATION DATE WAS NOT ON THE BOX OF ALCOHOL SWABS.
Additional Manufacturer Narrative
DATE OF EVENT: UNKNOWN. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. INITIAL REPORTER STATE: ADDRESS INFORMATION WAS NOT ABLE TO BE OBTAINED, THEREFORE, NJ WAS USED AS A PLACE HOLDER. INVESTIGATION SUMMARY: NO SAMPLES (INCLUDING PHOTOS) WERE RETURNED THEREFORE THE COMPLAINT COULD NOT BE CONFIRMED AND THE ROOT CAUSE IS UNDETERMINED. THIS IS THE 1ST COMPLAINT FOR THE REPORTED LOT NUMBER. DUE TO THIS BATCH BEING MANUFACTURED IN 2010 AND FILES ARE RETAINED FOR 7 YEARS, NO DHR REVIEW CAN BE COMPLETED.